Respiratory assembly

ABSTRACT

A respiratory assembly is provided. The assembly includes a base engaged with at least one connector and in fluid communication with a hose or fluid source for allowing the gaseous flowthrough between the at least one connector, the base and the hose or fluid source. The assembly further includes a pair of sockets engaged with the at least one connector, and a pair of posts, each post selectively engageable with at least one of the pair of sockets. Each post includes a flange that defines an opening therethrough, the openings in fluid communication with each corresponding socket of the pair of sockets. Each post further includes an adhesive adhered to each flange and configured for sealably engaging a patient&#39;s nare.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of International ApplicationNo. PCT/US2016/055834 filed Oct. 6, 2016, which is acontinuation-in-part of U.S. patent application Ser. No. 14/876,099filed Oct. 6, 2015, which is a continuation-in part of U.S. patentapplication Ser. No. 13/672,946 filed Nov. 9, 2012 and issued as U.S.Pat. No. 9,149,595, which claims priority to U.S. Provisional PatentApplication 61/562,056 filed on Nov. 21, 2011, the contents each ofwhich are each hereby incorporated by reference in their entirety.

This application also claims priority to U.S. Provisional PatentApplication 62/495,576 filed Sep. 13, 2016, the contents each of whichare hereby incorporated by reference in their entirety.

This application is also a continuation-in-part of U.S. Design patentapplication Ser. No. 29/577,512 filed Sep. 13, 2016, U.S. Design patentapplication Ser. No. 29/577,513 filed Sep. 13, 2016, and U.S. Designpatent application Ser. No. 29/577,515 filed Sep. 13, 2016, the contentseach of which are hereby incorporated by reference in their entirety.

TECHNICAL FIELD

This disclosure is related to a respiratory assembly, and moreparticularly a respiratory assembly having a nostril engaging portionfor providing sealable engagement with a treatment fluid.

BACKGROUND

Continuous positive air pressure (CPAP) masks are used for treatingpatients having any number of sleeping or breathing disorders duringsleeping. CPAP masks can deliver a treatment fluid, such as ambient airor oxygen enriched air to a patient under a predetermined or desiredpressure setting.

CPAP masks suffer from many disadvantages. For example, CPAP masks arebulky, making them less aesthetically and ergonomically pleasing. CPAPmasks must provide sealable engagement with the patient's skin in orderto maintain a sealed environment for achieving the desired pressure fortreatment fluid delivery. This sealable engagement leaves wear marks onthe patient's skin and may require undesirable amounts of time for thewear marks to disappear. Accordingly, many patients feel uncomfortablein public until the wear marks have disappeared, and male patients maynot be able to shave their faces and female patients not be able toapply makeup until the wear marks have disappeared. These depressions ormarks may be the result of the masks enveloping the mouth and/or thenostril, as well as the straps or connections that may be positionedabout the patient's head.

Due to the bulky nature of conventional CPAP masks, the masks occupy alarge portion of a person's face. This restricts the person's ability tomove their head during sleep because laying on the side of one's facemay contact the CPAP mask and dislodge the mask from sealable engagementwith the patient, thereby evacuating the pressure in the mask assembly.This is undesirable as either the patient is not receiving treatmentgases under the ideal pressures or the patient is awakened.

Accordingly, there is a need for an improved CPAP respiratory assemblythat addresses the disadvantages associated with conventional CPAPmachines and masks. Further, there is a need for a CPAP respiratoryassembly that is strapless and maskless, thereby addressing the bulkyand mark-forming nature of conventional CPAP machines and masks.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

According to at least one embodiment, a respiratory assembly isprovided. The respiratory assembly includes a pair of sockets in fluidcommunication with a fluid source; a pair of posts, each postselectively engageable with at least one of the pair of sockets, whereineach post includes: a flange that defines an opening therethrough, theopenings in fluid communication with each corresponding socket of thepair of sockets; an adhesive adhered to each flange and configured forsealably contacting a patient's nare without penetrating a nostril ofthe patient.

According to another embodiment, the assembly further comprises hook andloop fasteners for selectively engaging the sockets and the posts toeach other.

According to another embodiment, the assembly further comprises a baseengaged with at least one connector and in fluid communication with ahose or fluid source for allowing the gaseous flowthrough between the atleast one connector, the base and the hose or fluid source; the pair ofsockets engaged with the at least one connector.

According to another embodiment, wherein each of the pair of socketsincludes pinchers for permitting selective engagement between thesockets and the posts.

According to another embodiment, wherein each pincher includes at leastone collar pivotable by relative to the corresponding socket forselectively accepting one of the pair of posts within the correspondingsocket and engaging the corresponding post.

According to another embodiment, wherein each pincher further defines arecess between two collars for accepting and aligning the post relativeto the socket.

According to another embodiment, wherein each of the pair of socketsfurther includes a handle for manipulating each socket when acceptingand engaging the corresponding post.

According to another embodiment, wherein the adhesive includes abreathable foam for venting of carbon dioxide.

According to another embodiment, wherein the respiratory assembly ismaskless and strapless.

According to another embodiment, wherein the system includes twoconnectors, each engaged with one of the pair of sockets.

According to another embodiment, wherein the base defines four openingsfor engaging two connectors and two caps.

According to another embodiment, wherein the flange of the posts areangled relative to a post body defined by the posts, each post bodyselectively engaging the at least one of the pair of sockets.

According to another embodiment, the assembly further comprises ventsfor titrating fluids.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofpreferred embodiments, is better understood when read in conjunctionwith the appended drawings. For the purposes of illustration, there isshown in the drawings exemplary embodiments; however, the presentlydisclosed invention is not limited to the specific methods andinstrumentalities disclosed. In the drawings:

FIG. 1 illustrates a perspective view of a respiratory mask and apatient for being treated according to one or more embodiments disclosedherein;

FIG. 2 illustrates a perspective view of a mask according to one or moreembodiments disclosed herein.

FIG. 3 illustrates a perspective view of a nasal assembly and a patientfor being treated according to one or more embodiments disclosed herein;

FIG. 4 illustrates a perspective view of a portion of a nasal assemblyaccording to one or more embodiments disclosed herein;

FIGS. 5A and 5B illustrate respective perspective and side views of anasal assembly for use with a respiratory mask according to one or moreembodiments disclosed herein;

FIG. 6 illustrates a perspective view of respiratory assembly having abase and a single connector according to one or more embodimentsdisclosed herein;

FIG. 7 illustrates a back view of respiratory assembly having a base andtwo connectors according to one or more embodiments disclosed herein;

FIG. 8 illustrates a perspective view of a base of a respiratoryassembly having two base openings according to one or more embodimentsdisclosed herein;

FIG. 9 illustrates a bottom view of a base of a respiratory assemblyhaving two base openings according to one or more embodiments disclosedherein;

FIG. 10 illustrates a back view of a base of a respiratory assemblyhaving two base openings according to one or more embodiments disclosedherein;

FIG. 11 illustrates a back view of a base of a respiratory assemblyhaving four base openings and two caps according to one or moreembodiments disclosed herein;

FIG. 12 illustrates a cleat assembly and rotatable socket assemblyaccording to one or more embodiments disclosed herein;

FIGS. 13A-13D illustrate a socket assembly and a post according to oneor more embodiments disclosed herein;

FIG. 14A illustrates a perspective view of a socket assembly having aclamp lock according to one or more embodiments disclosed herein;

FIG. 14B illustrates a top view of a socket assembly having a clamp lockaccording to one or more embodiments disclosed herein;

FIG. 14C illustrates a side view of a socket assembly having a clamplock according to one or more embodiments disclosed herein;

FIG. 14D illustrates a bottom view of a socket assembly having a clamplock according to one or more embodiments disclosed herein.

FIG. 15 illustrates a perspective view of a socket having pinchers andtabs according to one or more embodiments disclosed herein.

FIG. 16A illustrates a perspective view of a connector and post having ahook and loop engagement according to one or more embodiments disclosedherein.

FIG. 16B illustrates a cross-sectional view of a connector and posthaving a hook and loop engagement according to one or more embodimentsdisclosed herein.

FIG. 17A illustrates a perspective view of a connector and socket havinga hook and loop engagement according to one or more embodimentsdisclosed herein.

FIG. 17B illustrates a cross-sectional view of a connector and sockethaving a hook and loop engagement according to one or more embodimentsdisclosed herein.

FIG. 18 illustrates a perspective view of a binocular-style respiratoryassembly according to one or more embodiments disclosed herein.

DETAILED DESCRIPTION

The presently disclosed invention is described with specificity to meetstatutory requirements. However, the description itself is not intendedto limit the scope of this patent. Rather, the inventors havecontemplated that the claimed invention might also be embodied in otherways, to include different steps or elements similar to the onesdescribed in this document, in conjunction with other present or futuretechnologies.

FIG. 1 illustrates a respiratory assembly installed upon a patient 1according to at least one embodiment. Such an embodiment is described indetail in U.S. patent application Ser. No. 13/672,946 filed Nov. 9, 2012and issued as U.S. Pat. No. 9,149,595. The respiratory assembly isgenerally designated as 10 throughout the drawings. The assembly 10includes a nasal assembly 12. The nasal assembly 12 may include at leastone post 14 with a nasal engaging portion 16 on or about a first endthereof for delivering treatment gases to the nasal cavity of thepatient 1. The post 14 may be configured for providing a flush, sealableengagement with the patient's nares.

The respiratory assembly 10 may include a mask assembly 20 having aninlet 22 for receiving treatment gases from a fluid source 41 and atleast one receptacle 24 for being sealably engaged with the post 14. Thefluid source 41 may be a continuous positive airway pressure (CPAP)machine, a fluid tank, a humidifier, or some other fluid source. Thepost 14 may be selectively engageable with the receptacle 24, such thatthe engagement is permanent or only when desired by the patient.Alternatively, the post 14 may be selectively engageable directly with atube 28 carrying treatment gases therethrough.

As illustrated in FIG. 2, the inlet 22 may include a swivel joint 36 forallowing swiveling movement of the inlet 22 about the mask assembly 20.The inlet 22 may be a hose 40 for providing flowthrough of treatmentgases from the fluid source 41 to the inlet 22.

The receptacle 24 may include a tube 28 configured for flexible movementto position the nasal assembly 12 to various sizes of respectivepatients' noses. The mask assembly 20 may be configured for sealableengagement with the patient's mouth by an adhesive pad 42 selectivelyengageable therewith and carried by the mask body 46. Within the maskbody 46 may be defined a chamber 58 through which treatment gases flowfrom the inlet 22. In this manner, in one operative condition, the maskassembly 20 may be sealably engaged with both the patient's mouth areawhile the nasal assembly 12 may be also engaged with the patient's naresor nasal area. In this operative condition, treatment gases may be beingsupplied to both the patient's mouth and their nasal areasimultaneously. The mask body 46 may further define a socket recess 38for cooperating with a joint described further herein.

Alternatively, panel 44 may be provided for sealable engagement with themask assembly 20 in order to seal off the chamber 58 so that treatmentgases do not pass into the area surrounding the patient's mouth andinstead pass only through to the nasal assembly 12. In this manner, theone or more devices 10 disclosed herein may be appropriately configuredfor both CPAP applications in which the patient receives treatment gasesto both their mouth and nose and in CPAP applications where the patientreceives treatment gases to only their nose. Additionally, one or moreplugs 48 may be provided for use with the mask assembly 20 to sealreceptacles 24 if the patient does not desire use of the nasal engagingconfiguration provided herein. Accordingly, the respiratory assembly 10described herein may have three distinct modes of operation: one inwhich treatment gases are being supplied to the patient's mouth only,one in which treatment gases are being supplied to the patient's noseonly, and one in which treatment gases are being supplied to thepatient's nose and mouth.

In one or more embodiments, the inlet 22 may further include a ball andsocket joint 50 as illustrated in FIG. 2, with ball being represented as50 and socket recess being represented by 38. The ball and socket jointallows for rotational movement of the inlet 22. The ball 50 may define aplurality of vents 52 for allowing flow of treatment gases therethrough.The vents 52 may be adjustable in size and location such thatmanipulation of all exhaled fluids such as carbon dioxide from thepatient is controlled and titratable such that the flow rate of fluidscan be altered to a desired setting. In alternative embodiments, asdepicted in FIGS. 3 and 4, each tube 28 of the pair of tubes 28, eachpost 14 of the pair of posts 14, or both may include vents or ventopening 52 for allowing gaseous flowthrough. Further, the vent openings52 may be adjustable for titration of gases therethrough. In someembodiments, vents 52 may be comprised of polymeric fibers, membranes orwebs with extremely small thickness from nanoscale to microscale.Polymeric fibers may be produced by electrospinning PTFE(polytetrafluoroethylene).

In one or more embodiments, the mask body 46 may include an adjustablemechanism that allows the tubing from the post 14 to be altered, movedor elevated to accommodate a patient's facial structure, primarily thedistance between the nose and the oral housing port on or inside body46, thereby allowing for ideal facial angles and facial length thatmight add to a patient's comfort. To further increase comfort, usabilityand effectiveness of the respiratory assembly 10, nasal assembly 12and/or mask assembly 20, software and printing capabilities can beemployed to customize the shape and contour of the various componentsrespiratory assembly 10 and/or nasal assembly 12. For example, but notlimited to, the nasal engaging portion 16 of the nasal assembly 12 maybe specifically contoured to fit each nasal passage of the patient 1.Such customization can be achieved by digitally scanning the features ofa patient's face to create a CAD model or for 3D printing. Further,various portions, or the whole of, the mask body 46 and/or adhesive pad42 may be customized to more effectively fit the facial contours of thepatient 1. Such customization may be applied to any component of therespiratory assembly 10, including, but not limited to, the nasalassembly 12, the base 90, the connector 91, the socket 94, the cleatassembly 80, the sheet 30, and/or the splitter 60.

FIG. 3 illustrates a nasal assembly 12 installed upon a patient 1according to at least one embodiment. The nasal assembly 12 may includea pair of tubes 28, each in gaseous communication with a hose 40 or afluid source 41. The pair of tubes 28 and the hose 40 may be unitarilyformed. Alternatively a splitter 60 may be positioned between each ofthe pair of tubes 28 and the hose 40 or the fluid source 41. Thesplitter 60 may be engaged with each of the pair of tubes 28 and thehose 40 or fluid source 41 for allowing the gaseous flowthrough betweeneach of the pair of tubes 28 and the hose 40 or the fluid source 41. Thesplitter 60, pair of tubes 28 and hose 40 may be unitarily formed.

The engagement of the splitter 60 with the tubes 28 and/or hose 40 orfluid source 41 may be achieved using a number of different structuralconfigurations. Some structural configurations may permit greaterpivotal movement between the elements 28, 40, 60, while at the same timemaintaining a sealable engagement for preventing leakage of gastherefrom. The splitter 60 may have two tube-engaging ends 62 forengaging the tubes 28 and one source-engaging end 64 for engaging thehose 40 or fluid source 41. The tubes 28 may include a tube splitterreceiver 66. The hose 40 or fluid source 41 may include a sourcesplitter receiver 68. In some embodiments, the receivers 66, 68 orengaging ends 62, 64 may be circumferentially extending structuresengaged with corresponding recess structures. Alternatively, thereceivers 66, 68 or engaging ends 62, 64 may be splitter or tube socketsengaged with corresponding tube or splitter ball joints for allowingpivotal movement of the tubes 28 about the splitter 60.

In at least one embodiment, such as the embodiment depicted in FIG. 4,each post 14 of the nasal assembly 12 may include an extending portion34 for selectively engaging a respective receiving portion 35 of thepair of tubes 28. The engagement of the post 14 with the receptacle 24or tube 28 may be achieved using a number of different structuralconfigurations. The extending portion 34 may be a circumferentiallyextending portion for selectively engaging a respective recess receivingportion 35. Alternatively, the extending portion 34 may be a post balljoint and the receiving portion 35 being a tube socket, and wherein thepost ball joint 34 and the tube socket 35 are configured for selectiveengagement for allowing pivotal movement of the pair of tubes 28 abouteach of the pair of posts 14, as depicted in FIG. 4. Another alternativeembodiment may include the extending portion 34 being a post socket andthe receiving portion 35 being a tube ball joint, wherein the postsocket 34 and the tube ball joint 35 are configured for selectiveengagement for allowing pivotal movement of the pair of tubes 28 abouteach of the pair of posts 14.

According to some embodiments, the nasal assembly 12 includes a pair ofposts 14. FIGS. 5A and 5B illustrate the nasal assembly 12 in greaterdetail according to at least one embodiment. The post 14 may include aflange 26 configured for engaging with a sheet 30 having an adhesive 32applied thereon, or alternatively, a layer of adhesive 32, or a layer ofadhesive inclusive of a sheet 30, for being adhered and providingsealable engagement with the nostrils of the patient 1. The sheet 30 mayhave any desired shape, and may preferably include an opening thereinfor allowing flowthrough in an opening 29 defined in the post 14. Theadhesive 32 may be a pressure sensitive adhesive such that the sheet 30may be adhered and removed from the patient's nostrils as desired. Thepost 16 may include an extending portion 34 on a second end thereof thatis configured for selective engagement with the at least one receptacle24 or corresponding tube 28 of the pair of tubes 28.

The adhesive 32 (and/or sheet 30) may have varying thicknesses, adhesivestrengths and flexibility. The thickness, adhesive strength andflexibility may vary between each adhesive 32 and/or may vary withineach individual adhesive 32 itself. For example, the flexibility of theadhesive 32 may be more rigid about the nostril-engaging portions, whilemore flexible elsewhere. The adhesive 32 may be comprised of a foammedical tape, a surgical tape and/or a hypoallergenic tape. The adhesive32 may comprise a hydrocolloid tape and/or may include a polyurethanereactive layer that confirms more with the nostril as the patient's bodytemperature warms up the adhesive 32. The adhesive 32 may include apolyvinyl chloride or polyolefin foam tape and/or an acrylate adhesivelayer. In some embodiments, the adhesive 32 may include a cloth layerfor adhering to the post 14 using an adhesive substance or tape. Theadhesive 32 may include a foam layer between the adhesion to the nareand the post 14. The foam layer may permit CO2 venting. Further, thefoam layer may permit flexibility between the post 14 and nare withoutdisengaging from either.

In some embodiments, each post 14 of the pair of posts 14 may include aflange 26 that defines an opening 29 therein, the openings 29 in gaseouscommunication with each corresponding tube 28 of the pair of tubes 28.Further, an adhesive 32 or layer of adhesive 32 may be applied to eachpost 14, each post 14 configured for sealably engaging a patient's nare.The adhesive 32 may be applied to a sheet 30 positioned on a nasalfacing side of the post 14, or the adhesive may be applied directly tothe flange 26 of the post 14. The adhesive 32 may be pressure sensitive.In some embodiments of the invention, the posts 14 described herein maybe used in combination with a micro-CPAP device having micro-blowers,where positive and negative charges collapse plates into engagement witheach other, forcing air to and through the posts 14 into the nostril ofthe patient.

FIG. 6 illustrates a perspective view of respiratory assembly 10 havinga base 90 and a single connector 91 according to one or more embodimentsdisclosed herein. Notably, the embodiments of FIGS. 6, 8 and 11 are bothstrapless and maskless—a significant advantage over the prior art, wherestraps and masks often leave marks on the patient's body. The base 90may include any number of vents 52. For example, as is illustrated inFIG. 9, the vents 52 may be positioned on the bottom side of the base90. The base 90 may further include or define a base tube engagement 103for selectively engaging or coupling to a hose 40 or fluid source 41.The engagement or coupling between the base tube engagement 103 and thehose 40 or fluid source 41 may permit full rotation of the two inrelation to each other. The base 90 and base tube engagement 103 may beunitarily formed or formed separately. The base tube engagement 103 mayinvolve any of the engagements described herein, including but notlimited to a ball and socket joint, snap engagement, pinch engagement,cleat engagement or other form of engagement. The base tube engagement103 may include vents 52 or may include a textured or contoured surfacefor easier maneuverability and operation of the respiratory assembly 10.

The vents 52 of the present invention may be positioned proximal to anyof the regions where fluid flow occurs. For example but not limitedthereto the vents 52 may be placed on the base 90, connector 91, posts14, socket 94, base tube engagement 103, etc. The vents 52 may bemanufactured using a 3D thermoplastic printing process. The vents 52 maybe comprised of microscopic pores. The microscopic pores may be createdusing a matrix of very thin fibrils. The fibrils may be comprised ofpolytetrafluoroethylene (PTFE).

In other embodiments, the vents 52 may be comprised of hook and loopfasteners 53. For example, but not limited thereto, the hook and loopfasteners 53 may act as connections between various components of therespiratory assembly 10. Turning to FIG. 16, an embodiment of theinvention is shown where hook and loop fasteners 53 acting as vents 52are used to connect the connector 91 to the post 14. By using hook andloop fasteners 53 as the selective engaging connection between variouscomponents of the respiratory assembly 10, such as between the connector91 and post 14, the assembly 10 thereby permits exhaled carbon dioxideto exit the assembly 10. In some embodiments, the use of hook and loopfasteners 53 as vents 52 would permit the assembly 10 to be free ofother vents 52, such as the vents depicted in FIGS. 6 and 9.

The base 90 and single connector 91 may be unitarily constructed orconstructed separately. For example, the base 90 may be comprised of ahard plastic and the connector 91 may be comprised of silicone. The base90, socket 94, posts 14 and/or other components of the respiratoryassembly 10 may be comprised of a plastic, for example but not limitedto polypropylene or polyethylene, which may be of food or medical gradequality. The possibility of unitary or separate construction, and theinclusion of plastics and silicone, may additionally apply to theembodiments depicted in FIGS. 8 and 11, for example, and otherembodiments described herein. The connector 91 of FIG. 6 defines aconnector body 92 and two connector arms 93. The connector arms 93 mayeach be selectively engageable or coupled with a socket 94. The socket94 may engage or couple the interior of the connector arm 93 (see FIG.6), the exterior of the connector arm 93 or both the interior and theexterior. In one embodiment, the socket 94 may engage the connector arm93 (and/or the post 14 may engage the socket 94) by sliding into agrooved cavity of the connector arm 93 (and/or socket 94).

A base 90 may be provided for receiving the liquid flow from the hose 40or fluid source 41. The base 90 may further define at least one baseopening 96. For example, FIG. 6 depicts an embodiment wherein the baseincludes a single base opening 96 for selectively engaging or couplingto the connector 91. In other embodiments, such as FIGS. 8 and 11, forexample, the base may include more than one base opening 96—two in FIG.8 and four in FIG. 11. Any number of base openings 96 may be includedfor providing various configurations adapted to the contours of variouspatients 1. Further the engagement or coupling of the one or more baseopenings 96 and the one or more connectors 91 may be effected using anyof the engagements described herein.

FIG. 7 illustrates a back view of respiratory assembly 10 having a base90 and two connectors 91 according to one or more embodiments disclosedherein. The base 90 may define a base concavity 97 for allowing freermovement of the patient's lips, or access thereto, by being shaped awayfrom the patient's face when the respiratory assembly 10 is engaged withthe patient's nares. Further, the base 90 may include one or more basebulges 98 and a base dip 99 for minimizing the volume being used by therespiratory assembly 10, thereby allowing greater access to thepatient's face and easier manipulation of various components of therespiratory assembly 10.

The base 90 of FIG. 7 defines two base openings 96 for selectivelyengaging or coupling to each of at least two connectors 91. More thantwo connectors 91 may be provided such that the connectors 91 may beinterchanged as desired, for varying the shape (and therefore airflow),angle (and therefore position) and/or type, which may include any of theengagements described herein. Each connector 91 may be shaped andcomprised of materials for deformability, such that the connector arms93 may be flexed in relation to the connector body 92. Sockets 94 may beincluded in the respiratory assembly 94 for selectively engaging orcoupling to the connectors 91.

FIG. 8 illustrates a perspective view of a base 90 of a respiratoryassembly 10 having two base openings 96 and a base tube engagement 103according to one or more embodiments disclosed herein. FIG. 9illustrates a bottom view of a base 90 of a respiratory assembly 10having two base openings 96 according to one or more embodimentsdisclosed herein. FIG. 10 illustrates a back view of a base 90 of arespiratory assembly 10 having two base openings 96 according to one ormore embodiments disclosed herein.

FIG. 11 illustrates a back view of a base 90 of a respiratory assembly10 having four base openings 96 and two caps 102 according to one ormore embodiments disclosed herein. The two caps 102 may cover the baseopenings 96 when not in use and/or when the base openings 96 are notengaged or coupled to connectors 91. The base openings 96 may besimilarly sized and shaped such that connectors 91 may be interchangedand repositioned freely amongst each of the openings 96. Suchcustomization permits a patient to selectively engage or couple theconnectors 91 to any two openings 96 for a best fit to the patient'snare. By permitting cleat engagements or ball and joint engagements orany other engagement permitting multiple positioning, and/or byproviding angled posts 14 and/or connectors 91, the connector 91,connector arm 93 and/or posts 14 may be positioned to best fit thepatient's nare when the respiratory assembly 10 is engaged.

FIG. 12 illustrates a cleat assembly 80 and rotateable socket assembly94 according to one or more embodiments disclosed herein. The sheet 30of the respiratory assembly 10 may be embedded with a cleat assembly 80,wherein the cleat assembly 80 defines a cleat flange 82 extendingbetween layers of the sheet 30. Alternatively, the sheet 30 and/oradhesive 32 may be applied to a nasal-facing side of the cleat flange 82of the cleat assembly 80, similar to the nasal engaging portion 16 ofthe post 14 described herein. The sheet 30, nasal engaging portion 16and/or cleat flange 82 may be formed to create various shapes in orderto fit the numerous types of nares and nostrils of patients. Forexample, in FIG. 6 the sheet 30 is substantially circular about the nare4 (see FIG. 1) and extends outward on one side in a triangular mannerwith a curved apex; such an embodiment provides a greater surface areafor adhering to the patient 1. In FIG. 5, the sheet 30 is substantiallycircular. Throughout the description, cleat flange 82 and nasal engagingportion 16 may be interchangeable used. In other embodiments, the sheet30, nasal engaging portion 16 and/or cleat flange 82 may be radiallyundulating, concave or convex so as to conform to the nostril in aconforming manner. Upon application to the patient 1, the sheet 30and/or cleat flange 82 may overlap between the nares 4 for providingadditional support and adhesion. The cleat flange 82 may be similarlyshaped and arranged.

The cleat flange 82 of the cleat assembly 80 may be rigid for providingsupport or flexible for conforming to the shape of the patient's nare 4and nostril 3. The cleat assembly 80 may further define cleat extension84 extending from a central or inner portion of the cleat flange 82 andaway from the patient 1. The cleat extension 84 may be substantiallycylindrical, or may be alternatively shaped, for engaging a post 14 orsocket 94 of the nasal assembly 12. The cleat extension 84 may define aplurality of cleat ridges 86 within the interior of the cleat extension84—the cleat opening 85—and/or the exterior of the cleat extension 84.The cleat ridges 86 may each define a distal end 87 positioned furtherfrom the cleat flange 82 than the proximal end 88 defined by the cleatridge 86. The distal and proximal ends 87, 88 may be arranged forpermitting either clockwise or counterclockwise rotation of the post 14or socket 94 in relation to the cleat assembly 80. Further, the cleatridges 86 may define a tapered edge 89 on the distal end 87 and/or theproximal end 88 for facilitating smooth rotation and locking of thecleat assembly 80 and the post 14 or socket 94.

In alternative embodiments, the cleat ridges 86 and post or socket ridge110 may be L-shaped and the cleat assembly may further a spring-basedring (not shown) positioned on the cleat flange 82. During engagement ofthe post 14 or socket 94 with the cleat assembly 80, the ridges may bepushed past each other and the post 14 or socket 94 may be twisted,then, upon release by the patient, the spring-based ring would ‘lock’the cleat assembly 80 and post 14 or socket 94 into place. Socket ridge110 may define a proximal socket end 112 and a distal socket end 114similar to the proximal and distal ends 87, 88 of the cleat ridge 86.

Although a socket 94 is depicted in FIG. 12, a post 14 may similarly beselectively engageable with the cleat assembly 80. The socket 94 or post14 may include position identifiers (A-H) for permitting the patient toselectively engage the socket 94 or post 14 into a particular desiredposition by lining up the desired position identifier (A-H) with thecleat position identifier 104. The socket 94 or post 14 may furtherdefine gripping features 105 for easily rotating the socket head 106.The socket head 106 may be freely rotatable about the socket base 107.In other embodiments (FIGS. 13A-D), the socket base 107 may be shapedfor engagement with the connector 91 and/or connector arm 93. Further,the socket 94 or post 14 may include a deformable o-ring 108 for sealingthe engagement or coupling of the socket 94 or post 14 to the cleatassembly 80 when engaged. In one embodiment, where the socket 94 engagesor couples to the exterior of the connector arm 93, the connector arm 93may extend within the socket 94 and define an o-ring 108 for sealing thesocket-post 94-14 engagement or coupling.

FIGS. 13A-D illustrate a socket assembly 94 and a post 14 according toone or more embodiments disclosed herein. The post 14 may include anasal engaging portion 16 which is angled in relation to the post body17 for enhanced positioning of the nasal engaging portion 16 in relationto a nare. The angle may be 15 degrees or any degree between 0 and 45.The angle may be created by having a portion of the post body 17 ‘bulge’outwards at an angle, as is depicted in FIGS. 13B and 13C. Theintersection of the bulge 17A and the post body 17, or the entire bulge17A itself, may be flexible or deformable and may be comprised ofdiffering material than the other portions of the post body 17.Alternatively, the post body 17 may remain substantially cylindrical,having a top portion ‘sliced’ at an angle.

The socket assembly 94 may include one or more pinchers 117 for engagingand disengaging the socket 94 from the post 14. The pinchers 117 mayextend from a collar 119 of the socket 94 distal the connector 91 and/orsocket base 107. The pinchers 117 may extend from the collar 119 at anangle for providing leverage to the pincher 117 when being ‘pinched’,therefore enabling the collar 119 of the socket to be deformed away fromthe post 14 for easy release. A pincher bridge may extend from betweenthe pincher 117 to the collar 119 and below the collar 119 for providingleverage to the collar 119 when the pincher 117 is pinched, instead ofmerely permitting the pincher 117 to pivot about the connection betweenthe pincher 117 and collar 119.

A socket cavity 118 may be defined by the socket 94 for permittingdeformation of the collar 119 when the pinchers 117 are pinched. Forexample, in FIG. 13D, the socket cavity 118 extends between the collars119 of the socket 94 and horizontally beneath the collars 119 forpermitting deformation of the collar 119 when the pinchers 117 arepinched. Pinching involves placing pressure on the one or more pinchers117, either individually or simultaneously, so that a distal end of thepinchers 117 are flexed towards the socket 94, thereby lifting aproximal end of the pincher 117, the collar 119, and/or the collar bead130 and permitting the release of the barb 132 of the post 14, forexample.

FIGS. 14A-14D illustrates a socket assembly 94 having a clamp lock 120according to one or more embodiments disclosed herein. The clamp lock120 may include two clamp extensions 121. The first clamp extension 121Amay defined a first clamp mound 122A and the second clamp extension 121Bmay define a second clamp mound 122B. One or both of the clamp mounds122 may include a clamp ridge 123 for permitting the clamp mounds 122 tobe lockingly engaged when the extensions 121 are pinched together. Onceengaged, the clamp mounds 122 may be disengaged with a subsequent pinch.In one embodiment, pinching the extensions 121 together engages the bead130 with the post 14 for securing the post 14 in position. The post 14may define positioners 132 (small protrusions on the underside of thepost, distal from the nasal engaging portion 16) for further securingthe post 14 position and resisting rotation of the post 14 when thepositioners 132 are engaged with the position apertures 134 defined bythe socket 94.

FIG. 15 illustrates a perspective view of a socket 94 having pinchers117 and a handle portion 140 according to one or more embodimentsdisclosed herein. A socket 94 may include any number of pinchers 117. InFIG. 15, two pinchers 117 are positioned opposite each other on thesocket 94 and are coupled to the socket 94 along a pincher groove 154proximal a sealing ring 162 of the socket 94. The pincher groove 154 maybe configured for flexing to permit the pinchers 117 to be easilymaneuvered. Each pincher 117 may include a pincher body 156 extendingfrom the groove 154 and/or the sealing ring 162 of the socket 94 towardsa collar 119. Extending in the opposite direction of the body 156 may bea pincher arm 158 for pivoting the collar 119 and pincher body 156. Insome embodiments, the pinchers 117 may define gripping features 144thereon. The gripping features 144 may include ridges, grooves, or otherfrictional elements for improving grip.

The pinchers 117 may define a collar 119 configured for accepting andgripping a post 14 when the post 14 is slidingly engaged with the collarof the socket 94. The collar 119 may define one or more collar beads 130positioned internally of the collar 119 and pincher 117 for selectivelyengaging the post 14. In some embodiments, the engagement of the collarbead 130 with the post 14, and/or the barb 132 of the post 14, mayproduce an audible ‘snap’ sound so as to alert the user that engagementhas been effected. The audible sound is particularly advantageousbecause the user may not be able to visually inspect the engagement ofthe post 14 and the socket 94 when positioned beneath the user's nose,for example. The pinchers 117 may define a pincher recess 160 extendingalong an internal portion of the pincher body 156 and the collar 119 foraccepting and aligning a portion of the post 14 when the post 14 isslindingly engaged with the socket 94; the pincher recess 160 may extendbetween two collar beads 130. The interior of the pincher body 156 maydefine a second pincher recess 161 on either side of the pincher recess160 for aligning the socket 94 and post 14 engagement and coupling. Thesecond pincher recess 161 may be shaped as an arc of a circle having adiameter greater than the circle defining the arc of the interior of thehandle body 143.

The sealing ring 162 of the socket 94 may engage the post 14 when thepost 14 is coupled to the socket 94 using the collar 119 of the pinchers117. The socket 94 may further define a handle portion 140 positionedbetween the pinchers 117 and extending from the sealing ring 162 of thesocket 94, or from a length below the sealing ring 162. The socket 94may define a void 164 between the pinchers 117 and the handle portion140 for permitting the pinchers 117 to be manipulated withoutinterference by an engagement with the handle portion 140. The void 164may extend through a portion of the sealing ring 162 as well.

The handle portion 140 may define a handle tab 142 extending externallytherefrom for sliding the socket 94 into engagement with the pinchers94. By using the handle portion and/or the handle tab 142 instead of thepinchers 117, the audible click of the pinchers 117 is much more likelyto occur and be heard, confirming coupling engagement of the socket 94and post 14. A handle bridge 150 may be defined between the handle tab142 and the handle body 143 for supporting the handle tab and lesseningthe flexibility of the handle tab 142 when pressure is applied. Theremay be more than one handle bridge 150 for each handle tab 142. Theremay be a single handle bridge 150 positioned centrally along a length ofthe handle tab 142. The handle tab(s) 142 may be sloped away from thehandle body 143, and may include a curved slope for conforming to theshape of a finger—the curve may extend across a length and/or a width ofthe handle tab 142. of the handle portion 140.

Notably, the pincher 117 and handle portion 140 embodiments describedherein with relation to the socket 94 and post 14 interaction could beapplied to other components of the respiratory assembly 10 whereselective engagement and/or coupling is desired. Other selectiveengagement and/or coupling mechanisms are also described herein and maybe used with other components of the respiratory assembly 10 as well.Turning to FIGS. 16A-17B, the use of hook and loop fasteners forselectively coupling and decoupling components of the assembly 10 isdepicted according to several embodiments of the invention; otherembodiments coupling other components of the system 10 may beenvisioned. For example, in FIGS. 16A and 16B, a connector 91 mayinclude a hook fastener and a post 14 may include a loop fastener eachshaped to nestingly engaged the other for selective coupling. In otherembodiments, the connector 92 may include the loop fastener and the post14 may include a hook fastener. In FIGS. 17A and 17B, a socket 94 iscoupled with the connector 92 using hook and loop fasteners 53. The hookand loop fasteners 53 may also be used to couple the socket 94 with thepost 14.

In FIG. 18, a binocular-style assembly is depicted. The hose 40 from thefluid source 41 may define a flexible portion 71 coupled to rigidportion 72. The rigid portion 72 may define a hose engagement 106 forengaging and/or rotatingly coupling with the splitter 60, a base 90 ofthe splitter 60, and/or a base tube engagement 103 of the splitter 60.The rotational coupling of the hose 40 and the splitter 60 with respectto each other permits customized positioning of the hose 40 when theassembly 10 and nasal assembly 12 are in use. The rotational couplingmay include any of the connection embodiments described herein,including an embodiment where a mound of the base tube engagement 103 isnestingly engaged with a groove and/or lip of the hose engagement 106for permitting the rigid portion 72 to be rotated about the splitterbase 90 for desired positioning. A hermetic seal may be produced by therotating coupling of the base tube engagement 103 and the hoseengagement 106.

As with other embodiments of the splitter 60 described herein, thesplitter 60 of FIG. 18 includes two connectors 91 extending from thesplitter base 90. The connector body 92 of each connector 91 may definea first portion 180 extending from the splitter base 90 and a secondportion 181 extending from the first portion 180. The second portion 181may be configured for allowing the connector arm 93 to rotate about thesecond portion 181 for permitting customized positioning of the socket94 with respect to the connector 91. A hermetic seal may be providedbetween the connector arm 93 and the connector body 92. Connectorapertures 178 may be defined by the second portion 181 of the connectorbody 92 for permitting air flow between the second portion 181 and theconnector arm 93. A connector end cap 174 may be defined by the secondportion 181 for sealing a distal end of the second portion 181 andsecuring the connector arm 93 onto the second portion 181 to preventsliding disengagement therefrom.

Each connector arm 93 may have less than forty-five degrees of rotation,less than ninety degrees of rotation, less than one-hundred and eightydegrees of rotation or a full three-hundred and sixty degrees ofrotation. One or both of the connector arms 93 may be rotatable withrespect to the connector body 92. By permitting the connector arm(s) 93to rotate independently of each other and/or the connector body 92, theconnector arm(s) 93 may be positioned to best fit the shape of a user'snose, whether the nose be wide or narrow, a single device may be used. Atension lock may be provided to lock the position of the connectorarm(2) 93. In some embodiments, sufficient friction may permanentlyexist between the body 92 and arm 93 allowing the arm 93 to be rotatedwhile maintaining its position when rotation is complete.

In some embodiments, the respiratory assembly 10, nasal assembly 12,mask assembly 20, and/or any components thereof may further include anoral device engagement for engaging an oral device engaged with thepatient's mouth. For example, but not limited to, the patient may have amouth guard, mandibular advancement splint or some other oral devicethat may be used in conjunction with the respiratory assembly 10, nasalassembly 12 and/or mask assembly 20. The oral device engagement mayselectively engage the respiratory assembly 10, nasal assembly 12 and/ormask 10 to the oral device for stabilizing the position of therespiratory assembly 10, nasal assembly 12 and/or mask 10 with respectto the patient 1.

In one or more embodiments, the respiratory assembly 10, or anycomponent thereof, may be provided as a short-term use product, suchthat the entire system is disposed of and replaced after a predetermineduse period. For example, the respiratory assembly 10 may be configuredfor use as a three month use product, such that the patient receives anew respiratory assembly 10 every three months. In one embodiment, thepost 14, cleat assembly 80 may be a disposable product. The patient mayinstall a new adhesive pad 42 and sheet 30 after each use.

While the embodiments have been described in connection with thepreferred embodiments of the various figures, it is to be understoodthat other similar embodiments may be used or modifications andadditions may be made to the described embodiment for performing thesame function without deviating therefrom. Therefore, the disclosedembodiments should not be limited to any single embodiment, but rathershould be construed in breadth and scope in accordance with the appendedclaims.

The invention claimed is:
 1. A respiratory assembly comprising: a baseengaged with at least one connector, wherein the base is in fluidcommunication with a hose or fluid source for allowing gaseousflowthrough between the at least one connector, the base, and the hoseor fluid source; a pair of sockets separable from the at least oneconnector, wherein the sockets are selectively engaged with the at leastone connector, wherein each socket is independently movable relative tothe other socket, wherein each socket defines: a collar; an openingdefined by the collar for receiving a post; wherein the collar has afirst mode of operation in which a post is engaged with the collar and asecond mode of operation in which the post is not engaged with thecollar through retraction of a locking member in response tomanipulation by a user; wherein each post is configured for sealablyengaging a patient's nare such that the post does not extend into arespective nostril of the patient when the post is engaged with thepatient's nare; and wherein the respiratory assembly is maskless andstrapless such that fluid from the hose or fluid source flows throughthe connector into the patient's nares but not into the patient's mouthwhen the respiratory assembly is worn by the patient.
 2. The respiratoryassembly of claim 1, wherein the posts sealingly engage the patient'snare through the use of a pressure sensitive adhesive.
 3. Therespiratory assembly of claim 2, wherein the adhesive comprises foam. 4.The respiratory assembly of claim 1, wherein the base further definestwo openings for engaging two connectors.
 5. The respiratory assembly ofclaim 1, wherein the base further defines four openings for engaging twoconnectors and two caps.
 6. The respiratory assembly of claim 1, whereineach post further includes a flange that is angled relative to a postbody defined by the posts, each post body selectively engaging the atleast one of the pair of sockets.
 7. The respiratory assembly of claim5, wherein the base further defines a concavity positioned at leastbetween two of the openings for providing access to the patient.
 8. Therespiratory assembly of claim 1, further comprising vents for titratingfluids.
 9. The respiratory assembly of claim 8, wherein the vents arepositioned on the base, connector, posts, socket, or combinationsthereof.
 10. The respiratory assembly of claim 1, wherein each of thepair of sockets further includes pinchers for permitting selectiveengagement between the sockets and the posts.
 11. The respiratoryassembly of claim 1, wherein each of the pair of sockets furtherincludes a clamp lock for permitting selective engagement between thesockets and the posts, wherein the clamp lock defines two clampextensions selectively engageable using at least one clamp ridge. 12.The respiratory assembly of claim 10, wherein the selective engagementfurther includes engaging the collar of the socket with a barb of thepost.
 13. A method of delivering one or more treatment gases to a nasalcavity of a patient, the method comprising: providing a respiratoryassembly comprising: a base engageable with at least one connector,wherein the base is in fluid communication with a hose or fluid sourcefor allowing gaseous flowthrough between the at least one connector, thebase, and the hose or fluid source; a pair of sockets separable from theat least one connector, wherein the sockets are selectively engaged withthe at least one connector, wherein each socket is independently movablerelative to the other socket, wherein each socket defines: a collar; anopening defined by the collar for receiving a post; wherein the collarhas a first mode of operation in which a post is engaged with the collarand a second mode of operation in which the post is not engaged with thecollar through retraction of a locking member in response tomanipulation by a user; wherein each post is configured for sealablyengaging a patient's nare such that the post does not extend into arespective nostril of the patient when the post is engaged with thepatient's nare; and wherein the respiratory assembly is maskless andstrapless such that fluid from the hose or fluid source flows throughthe connector into the patient's nares but not into the patient's mouthwhen the respiratory assembly is worn by the patient; engaging the basewith the at least one connector; engaging the post with the collar;sealably engaging the posts to the patient's nare, whereby one or moretreatment gases are delivered to the nasal cavity of the patient. 14.The method of claim 13, wherein the posts are sealably engaged to thepatient's nare using a pressure sensitive adhesive.
 15. The method ofclaim 14, wherein the adhesive comprises foam.
 16. The method of claim13, wherein the base further defines two openings for engaging twoconnectors.
 17. The method of claim 13, wherein the base further definesfour openings for engaging two connectors and two caps.
 18. The methodof claim 13, wherein the base further comprises vents for titratingfluids.